Evaluation of Metabolic Monitoring and Diabetes Incidence in the First Year for Veterans Newly Started on an Atypical Antipsychotic.

PURPOSE: This retrospective chart review is an evaluation of patient and health care provider adherence to a metabolic monitoring protocol as well as progression to type 2 diabetes mellitus (T2DM) in the first year after atypical antipsychotic initiation. METHODS: Patient (N = 1,651) data from February 2014 to February 2019 were collected from the US Department of Veterans Affairs (VA) Corporate Data Warehouse for 8 VA medical centers within Veterans Integrated Service Network (VISN) 21. Collected data included patient demographic, laboratory results, and medication history. RESULTS: In the final cohort, 6% of patients were found to have progressed to T2DM. Adherence to appropriate metabolic monitoring was found to be overall suboptimal. CONCLUSIONS: The findings of this project demonstrate that patients in VISN 21 who were previously antipsychotic-naïve and nondiabetic may be at increased risk of progression to T2DM when compared with the general population. To effectively manage patient risk, health care providers and patients should improve adherence to metabolic monitoring.

Evaluation of the potential impact of pharmacy technician performance of anticoagulation clinic tasks on operational efficiency.

PURPOSE: Results of a study to determine the proportion of anticoagulation clinic workload that could be performed by clinical pharmacy technicians (CPTs) and the potential impact on operational efficiency of pharmacist-managed anticoagulation clinics (ACCs) are reported. METHODS: In a quality improvement project involving 11 Veterans Affairs (VA) medical centers, investigators conducted a 3-day time study in pharmacist-managed ACCs followed by scoring of task appropriateness for CPTs via the RAND/UCLA appropriateness method by the VA Anticoagulation Subject Matter Expert (SME) Workgroup. The primary outcome was the percentage of tasks deemed appropriate for a CPT to perform. RESULTS: The Anticoagulation SME Workgroup determined that a wide variety of mainly administrative ACC tasks could be completed by a CPT. At the 11 VA ACCs, an average of 53.4% (range, 39.9-76.1%) of tasks being performed by pharmacists were deemed appropriate for CPTs. The average percentage of total clinic time associated with performing tasks appropriate for a CPT equated to an estimated 1,111 hours per year. Shifting that portion of the annual work hours to a CPT could potentially result in cost avoidance of $55,302. CONCLUSION: At the ACCs evaluated, a significant proportion of tasks (53.4% on average) may be appropriate to assign to CPTs to improve the operational efficiency of these clinics. This finding supports development of business plans for the addition of CPTs in ACCs along with elements to inform crafting of an effective template for ACC structure, including clearly defined CPT roles.

Utilizing Clinical Pharmacist Specialist to Manage Hepatitis C Virus Patients on Direct-Acting Antiviral Therapy.

OBJECTIVES: To evaluate outcomes of a clinical pharmacist specialist (CPS)-managed hepatitis C virus (HCV) treatment clinic (HCVTC) in treating HCV-infected veterans with direct-acting antivirals (DAAs). METHODS: We established a CPS-managed HCVTC under a collaborative practice agreement with our infectious disease physician (IDP). A total of 132 veterans were treated between November 1, 2014, and November 30, 2015. The CPS engaged in pretreatment screening, drug selection, patient education, medication counseling, drug therapy monitoring, drug utilization review, addressing issues on drug adherence, and routine and posttreatment follow-up of patients to assess sustained virologic response (SVR) after 12 weeks of treatment. RESULTS: Of 132 patients managed by the CPS, 87 (66%) were treated with ledipasvir/sofosbuvir (LDV/SOF), 29 (22%) with paritaprevir/ritonavir/ombitasvir + dasabuvir (PrOD), and 16 (12%) with sofosbuvir (SOF)-based regimen. The corresponding regimens demonstrated a SVR rate of 92% (n = 80), 100% (n = 29), and 93.8% (n = 15), respectively. We achieved an SVR rate of 94% against HCV genotype 1 (GT-1) and 100% against GT-2 to GT-4. The overall SVR rate was 94% across regimens, showing 93% in treatment-naive patients and 96% in treatment-experienced patients, and 93% in noncirrhotic and 94% in compensated cirrhotic patients. The results were comparable to SVR data reported in pivotal trials for DAAs. CONCLUSION: The results suggest that CPS could be effectively utilized in drug therapy management of HCV-infected patients treated with DAAs.

Docetaxel-induced cardiac-respiratory arrest in a patient with chronic atrial fibrillation.

Docetaxel has been approved by the Food and Drug Administration for the treatment of many cancer types, including breast cancer, head and neck cancer, lung cancer, and prostate cancer. Many severe to life-threatening side effects (Grades 3-5) of docetaxel have been reported in clinical trials, case reports, and Food and Drug Administration Adverse Events Reporting System. These include anaphylactic reactions, febrile neutropenia, fluid retention, acute respiratory distress, pleural effusion, pneumonia, and peripheral neuropathy. There were fewer cardiac toxicities reported for docetaxel as compared to paclitaxel, which were less severe. In this report, we present a clinical case of docetaxel-induced cardiac-respiratory arrest in a 62-year-old Hispanic male patient with stable chronic atrial fibrillation, who has been recently diagnosed with metastatic prostate cancer. The cardiac event developed within 15 min of docetaxel infusion during the second cycle of chemotherapy despite using recommended premedication with corticosteroids.

The impacts of a pharmacist-managed outpatient clinic and chemotherapy-directed electronic order sets for monitoring oral chemotherapy.

Objectives Patients treated with oral chemotherapy appear to have less contact with the treating providers. As a result, safety, adherence, medication therapy monitoring, and timely follow-up may be compromised. The trend of treating cancer with oral chemotherapy agents is on the rise. However, standard clinical guidance is still lacking for prescribing, monitoring, patient education, and follow-up of patients on oral chemotherapy across the healthcare settings. The purpose of this project is to establish an oral chemotherapy monitoring clinic, to create drug and lab specific provider order sets for prescribing and lab monitoring, and ultimately to ensure safe and effective treatment of the veterans we serve. Methods A collaborative agreement was reached among oncology pharmacists, a pharmacy resident, two oncologists, and a physician assistant to establish a pharmacist-managed oral chemotherapy monitoring clinic at the VA Sierra Nevada Healthcare System. Drug-specific electronic order sets for prescribing and lab monitoring were created for initiating new drug therapy and prescription renewal. The order sets were created to be provider-centric, minimizing clicks needed to order necessary medications and lab monitoring. A standard progress note template was developed for documenting interventions made by the clinic. Patients new to an oral chemotherapy regimen were first counseled by an oncology pharmacist. The patients were then enrolled into the oral chemotherapy monitoring clinic for subsequent follow up and pharmacist interventions. Further, patients lacking monitoring or missing provider appointments were captured through a Clinical Dashboard developed by the US Department of Veterans Affairs (VA) Regional Office (VISN21) using SQL Server Reporting Services. Between September 2014 and April 2015, a total of 68 patients on different oral chemotherapy agents were enrolled into the clinic. Results Out of the 68 patients enrolled into the oral chemotherapy monitoring clinic, 31 patients (45%) were identified as having a therapy-related problem with their oral chemotherapy regimen on a gross measure for safety and appropriateness of medication management during the course of eight months follow-up between September 2014 and April 2015. In addition, the clinic helped to reestablish care for three patients (4.4%) who were lost to follow-up. The clinic identified 12 patients (17.6%) non-adherent to their prescribed regimen in some degree, where patients were suspected to miss doses due to delay in refilling prescriptions at least three days later than the expected date. However, these patients denied non-adherence. Among them, six patients (8.8%) were truly non-adherent. These patients stated that they had missed at least one day of therapy or were not taking the medication as prescribed. Medication regimen errors were discovered for five patients, accounting for a 7.3% medication-related error rate. Finally, seven patients (10.3%) were found to have an adverse reaction attributed to their oral chemotherapy. Two of them (2.9%) developed severe adverse reactions (Grade 3 and 4), which required hospitalization or immediate dose de-escalation. Conclusions The pilot clinic was able to identify current deficiencies and gaps in our practice settings for managing oral chemotherapy in a Veterans population. The oral chemotherapy monitoring clinic played a proactive role to identify preventable medication errors, monitor medication therapy, improve adherence, manage adverse drug reactions and re-establish care for patients who were lost to follow-up. The results suggest that close monitoring and follow-up of patients on oral chemotherapy is crucial to achieve therapeutic goals, improve patient safety and adherence, and to reduce drug adverse events and health care cost.

Comparing fracture absolute risk assessment (FARA) tools: an osteoporosis clinical informatics tool to improve identification and care of men at high risk of first fracture.

BACKGROUND: Fracture absolute risk assessment (FARA) is recommended for guiding osteoporosis treatment decisions in males. The best strategy for applying FARA in the clinic setting is not known. OBJECTIVES: We compared 2 FARA tools for use with electronic health records (EHRs) to determine which would more accurately identify patients known to be high risk for fracture. Tools evaluated were an adaptation of the World Health Organization's Fracture Risk Assessment Tool used with electronic data (eFRAX) and the Veterans Affairs (VA)-based tool, VA-FARA. METHODS: We compared accuracies of VA-FARA and eFRAX for correctly classifying male veterans who fractured and who were seen in the VA's Sierra Pacific Network in 2002-2013. We then matched those cases to nonfracture controls to compare odds of fracture in patients classified as high risk by either tool. RESULTS: Among 8740 patients, the mean (SD) age was 67.0 (11.1) years. Based on risk factors present in the EHR, VA-FARA correctly classified 40.1% of fracture patients as high risk (33.0% and 34.6% for hip and any major fracture, respectively); eFRAX classified 17.4% correctly (17.4% for hip and 0.2% for any major fracture). Compared with non-high-risk patients, those classified as high risk by VA-FARA were 35% more likely to fracture (95% CI = 23%-47%; P < 0.01) compared with 17% for eFRAX (95% CI = 5%-32%; P < 0.01). CONCLUSIONS: VA-FARA is more predictive of first fracture than eFRAX using EHR data. Decision support tools based on VA-FARA may improve early identification and care of men at risk.

Measuring use of psychotropic drugs in Veterans Affairs community living centers.

OBJECTIVE: To create an electronic reporting tool able to capture psychotropic medication use by residents admitted to Veterans Affairs (VA) community living centers (CLCs) and to compare data on frequency of use. DESIGN: Retrospective analysis using an electronic medical record (EMR) database. SETTING: CLCs within the Veterans Integrated Service Network (VISN) 21, which encompasses northern Nevada, northern California, and Hawaii. PARTICIPANTS: 4,626 nonrespite care veterans admitted to a VISN 21 CLC between 2009 and 2012. PROCEDURES: Medication administration data from the EMR database was compiled into a reporting tool. Frequencies calculated were used in comparisons against Centers for Medicare & Medicaid Services (CMS) data for non-VA long-term care facilities and against previous local VA methods. OUTCOME MEASURE: The primary outcome was to develop a tool that would more accurately capture psychotropic drug use within VA CLCs. The secondary objectives were to use the tool to compare psychotropic use among VA facilities, against CMS data, and among various subgroups. RESULTS: There was a statistically significant difference when comparing psychotropic drug use for VISN 21 CLCs compared with use reported by CMS for non-VA long-term care facilities. CONCLUSIONS: Veterans in CLCs appear to use psychotropics at a significantly higher rate than residents in the community setting. Use of a real-time reporting tool can improve assessment of psychotropic drug use and create more realistic VA monitoring benchmarks.

Organizational characteristics of high- and low-performing anticoagulation clinics in the Veterans Health Administration.

OBJECTIVE: Anticoagulation clinics (ACCs) can improve anticoagulation control and prevent adverse events. However, ACCs vary widely in their performance on anticoagulation control. Our objective was to compare the organization and management of top-performing with that of bottom-performing ACCs. DATA SOURCES/STUDY SETTING: Three high outlier and three low outlier ACCs in the Veterans Health Administration (VA). STUDY DESIGN: Site visits with qualitative data collection and analysis. DATA COLLECTION/EXTRACTION METHODS: We conducted semi-structured interviews with ACC staff regarding work flow, staffing, organization, and quality assurance efforts. We also observed ACC operations and collected documents, such as the clinic protocol. We used grounded thematic analysis to examine site-level factors associated with high and low outlier status. PRINCIPAL FINDINGS: High outlier sites were characterized by (1) adequate (pharmacist) staffing and effective use of (nonpharmacist) support personnel; (2) innovation to standardize clinical practice around evidence-based guidelines; (3) the presence of a quality champion for the ACC; (4) higher staff qualifications; (5) a climate of ongoing group learning; and (6) internal efforts to measure performance. Although high outliers had all of these features, no low outlier had more than two of them. CONCLUSIONS: The top-performing ACCs in the VA system shared six relatively recognizable characteristics. Efforts to improve performance should focus on these domains.

Varenicline use in patients with mental illness: an update of the evidence.

IMPORTANCE OF THE FIELD: Patients with a psychiatric diagnosis have a higher prevalence of smoking compared to the general population. Varenicline is a first-line pharmacotherapy option to assist in smoking cessation. Clinical trials during drug development excluded patients with active psychiatric illnesses leaving the risks associated with varenicline use in this patient population unknown. AREAS COVERED IN THIS REVIEW: Literature published in English up to December 2009 were identified and include neuropsychiatric adverse drug events reported in pre-marketing trials and post-marketing surveillance, varenicline case reports, evidence surrounding the use of varenicline in patients with psychiatric diagnoses, and varenicline and suicidality. WHAT THE READER WILL GAIN: Although the risk of potential neuropsychiatric events is evident through voluntary reporting systems and reported cases in the literature, multiple studies and case reports support the use of varenicline in the mental health population. Reviewing the literature will enable clinicians to optimize patient care by weighing the risks and benefits associated with varenicline use against the risk of continued smoking. TAKE HOME MESSAGE: Cautious treatment initiation, patient education, and close follow-up, monitoring for mood and behavior changes during therapy are recommended, especially in the psychiatric setting.

Safety and effectiveness of varenicline in a veteran population with a high prevalence of mental illness.

BACKGROUND: Varenicline is a selective nicotinic receptor partial agonist used to aid in the process of smoking cessation. Research on varenicline's approval for marketing demonstrated that after 12 weeks of treatment, at least 44% of patients successfully quit smoking and, on average, 13% of individuals discontinued therapy due to an adverse drug event (ADE). Growing postmarketing data linked varenicline to an increase in neuropsychiatric symptoms. OBJECTIVE: To evaluate the safety profile, specifically psychiatric symptoms, and effectiveness of varenicline in a veteran population and to determine whether there is an association among specific baseline demographics and success rate. METHODS: The study was a retrospective review of a prospective performance measure involving veterans initiated on varenicline. Patients were contacted via telephone throughout treatment and at week 12 for effectiveness follow-up. Smoking history was obtained and medication counseling was provided. The primary endpoint was tobacco cessation between weeks 9 and 12 of therapy. Varenicline's safety profile and discontinuation rates due to ADEs were also analyzed. RESULTS: Of the 50 patients included in the study, 30% (n = 15) successfully quit smoking and 70% (n = 35) failed therapy (lack of effectiveness, n = 22; intolerability, n = 13). Prevalence of underlying mental illness in the success group (4/15; 27%) versus failure group (20/35; 57%) was statistically significant (p < 0.001). All patients who discontinued therapy due to an increase in mood and behavioral changes (n = 4) had an underlying psychiatric illness. The study results demonstrate a lower success rate and a higher incidence of discontinuation due to an ADE in our veteran population compared with premarketing data. An inverse association was shown between psychiatric disorders and success. CONCLUSIONS: Cautious treatment initiation and close monitoring of veterans initiated on varenicline are warranted. Furthermore, the results from this study demonstrate the need for prospective effectiveness trials to determine the clinical significance of the results.

Establishment and outcomes of a model primary care pharmacy service system.

PURPOSE: The establishment and outcomes of a model primary care pharmacy service system are described. SUMMARY: A primary care pharmacy practice model was established at a government health care facility in March 1996. The original objective was to establish a primary pharmacy practice model that would demonstrate improved patient outcomes and maximize the pharmacist's contributions to drug therapy. Since its inception, many improvements have been realized and supported by advanced computer and automated systems, expanded disease state management practices, and unique practitioner and administrative support. Many outcomes studies have been performed on the pharmacist-initiated and -managed clinics, leading to improved patient care and conveying the quality-conscious and cost-effective role pharmacists can play as independent practitioners in this environment. These activities demonstrate cutting-edge leadership in health-system pharmacy. Redesign has been used to improve consistent access to a medication expert and has significantly improved the quality of patient care while easing physicians' workload without increasing health care costs. CONCLUSION: A system using pharmacists as independent practitioners to promote primary care has achieved high-quality and cost-effective patient care.